Haemonetics Senior Quality Systems Engineer in Mexico
Title: Senior Quality Systems Engineer
Job Number: 171111754
Responsible for developing and coordinating implementation of quality systems, procedures, test methods, problem definitions and resolutions for existing and new products, in compliance with QMS.
• Conducts internal or external audits as assigned to ensure compliance to company quality system requirements.
• Develops, reviews and challenges existing quality driven test systems and procedures to assure products meet intended use.
• Insures that full range of black belt tools are used when appropriate for product and process changes in Braintree plan, particularly new products.
• Key contributor in the design review of new or modified products. Challenge design assumptions to assure design intent manufacturability and customer acceptance levels are achieved and in compliance with Haemonetics SOPs and regulatory standards.
• Leads product improvement projects and consults on supplier changes to ensure qualifications are met.
• Leads teams/projects related to Complaint investigation, CAPA, cost reduction, and quality system excellence. Use of TQM tools including Six Sigma is required.
• Maintains records to ensure compliance to GMP/ISO requirements.
• May lead design review of new platforms and assures that appropriate tests are performed to achieve sigma level expectations for quality.
• May maintain an active role in supplier and new business assessment and development.
• May manage and lead CAPA program, implementing global CAPA policies.
• Required to have specific product or process expertise to fit business needs
Required Bachelor's Degree Engineering or a Life Science discipline or a related technical field
Required 3 years Work experience
Licenses and Certifications:
Required Computer knowledge and experience with Microsoft Office
Required Six Sigma certification, black belt level
Candidate Background: Skills, Knowledge & Ability: Minimum requirements:
Required Work experience